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Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

NCT02866175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1506

Last updated 2020-05-06

Study results available
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Summary

There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

Conditions

Interventions

DRUG

Edoxaban

Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects

DRUG

Clopidogrel

Clopidogrel 75 mg once-daily

DRUG

Prasugrel

prasugrel 5mg or 10 mg once-daily

DRUG

Ticagrelor

ticagrelor 90 mg twice-daily

DRUG

Vitamin K antagonist

VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive

Sponsors & Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    lead INDUSTRY

Principal Investigators

  • Pascal Vranckx, MD · Hartcentrum Hasselt

  • Andreas Gotte, Prof., MD · Medizinische Klinik II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2019-06-06
Completion
2019-06-06

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866175 on ClinicalTrials.gov